探讨血清鳞状细胞癌抗原(SCC-Ag)在宫颈鳞状细胞癌(SCC)新辅助化疗(NACT)前、后的变化，以及对宫颈SCC患者进行NACT敏感性的预测价值。

选择2009年1月至2017年1月，在山西医科大学第二医院妇产科进行手术治疗前接受NACT，并且术中切除组织病理学检查结果证实为宫颈SCC的68例患者为研究对象。对宫颈SCC患者的NACT疗效进行分析。采用配对t检验和配对χ²检验，分别对NACT前、后血清SCC-Ag值及其阳性率进行比较。采用受试者工作特征(ROC)曲线下面积(AUC)对NACT前血清SCC-Ag值及NACT前、后血清SCC-Ag值变化，对宫颈SCC的NACT疗效的预测价值进行分析。采用多因素非条件logistic回归分析，对宫颈SCC的NACT疗效影响因素进行分析。采用χ²检验或Fisher确切概率法，对宫颈SCC患者NACT前、后血清SCC-Ag阳性率及其临床病理特征的关系进行分析。采用成组t检验，对复发与未复发宫颈SCC患者接受NACT前血清SCC-Ag值进行比较。本研究符合2013年修订的《世界医学协会赫尔辛基宣言》的要求，征得所有受试者知情同意，并签订临床研究知情同意书。

①宫颈SCC患者的NACT有效率为75.0%(51/68)。②本组68例宫颈SCC患者接受NACT后，血清SCC-Ag值及其阳性率分别为(2.9±1.6)ng/mL和45.6%(31/68)，均分别显著低于接受NACT前的(5.1±1.7)ng/mL和91.2%(62/68)，并且差异均有统计学意义(t＝7.991，P<0.001；χ²＝32.682，P<0.001)。③NACT前血清SCC-Ag值及NACT前、后血清SCC-Ag值变化值对于预测宫颈SCC患者NACT疗效的ROC-AUC分别为0.839(95%CI：0.717～0.965，P<0.001)与1.000(95%CI：1.000～1.000，P<0.001)，最佳临界值分别为3.0、0.6 ng/mL。④对宫颈SCC患者NACT疗效影响因素进行多因素非条件logistic回归分析的结果显示，NACT前血清SCC-Ag值及NACT前、后血清SCC-Ag值变化值均为预测宫颈SCC患者NACT敏感性的独立影响因素(OR＝0.365，95%CI：0.224～0.608，P<0.001；OR＝0.984，95%CI：0.899～0.998，P<0.001)。⑤本研究68例宫颈SCC患者中，合并脉管转移者，其接受NACT前的血清SCC-Ag阳性率高于未合并脉管转移者，合并淋巴结转移者、脉管转移者及国际妇产科联盟(FIGO)临床分期为Ⅱ_A2期患者接受NACT后的血清SCC-Ag阳性率，均分别高于未合并淋巴结转移者、脉管转移者及Ⅰ_B2期患者，并且差异均有统计学意义(P＝0.007，P<0.001，P＝0.035，P<0.001)。⑥本组68例宫颈SCC患者中，13例发生复发，复发率为19.1%(13/68)。复发者接受NACT前的血清SCC-Ag值为(7.1±1.1)ng/mL，高于未复发者的(4.7±1.5)ng/mL，并且差异有统计学意义(t＝5.253，P<0.001)。

血清SCC-Ag值及其变化是否可作为预测宫颈SCC患者NACT敏感性的指标，以及预测宫颈SCC复发的指标，因本研究纳入样本量较小，尚待大样本、多中心、随机对照试验进一步研究、证实。

To explore the changes of serum squamous cell carcinoma antigen (SCC-Ag) before and after neoadjuvant chemotherapy (NACT) in cervical squamous cell carcinoma (SCC), and to assess its predictive values of NACT sensitivity in cervical SCC.

A total of 68 patients who underwent NACT before surgery and were diagnosed as cervical SCC by postoperative biopsy from January 2009 to January 2017 in the Second Hospital of Shanxi Medical University were selected as research subjects. The efficacy of NACT in treatment of patients with cervical SCC were analyzed. Serum SCC-Ag values and its positive rates before and after NACT were compared by paired-samples t test and paired-chi-square test, respectively. The area under curve (AUC) of receiver operating characteristic (ROC) was used to analyze the predictive values of serum SCC-Ag value before NACT and changes of serum SCC-Ag values before and after NACT in NACT sensitivity of cervical SCC. Multiple unconditional logistic regression analysis was used to analyze the influencing factors of NACT efficacy in cervical SCC. Chi-square test or Fisher′s exact test was used to analyze the relationship between the positive rate of serum SCC-Ag before and after NACT in cervical SCC patients and their clinicopathological characteristics. Independent-samples t test was used to compare serum SCC-Ag values in cervical SCC patients with recurrent and non-recurrent before receiving NACT. This study met the requirements of the World Medical Association Declaration of Helsinki revised in 2013. And every subject signed an informed consent form.

①The efficacy of NACT in treatment of patients with cervical SCC was 75.0% (51/68). ②The value and positive rate of serum SCC-Ag after NACT in 68 patients with cervical SCC were (2.9±1.6) ng/mL and 45.6% (31/68), respectively, which were significantly lower than those before NACT (5.1±1.7) ng/mL and 91.2% (62/68), and both the differences were statistically significant (t=7.991, P<0.001; χ²=32.682, P<0.001). ③The ROC-AUC of serum SCC-Ag value before NACT and changes of serum SCC-Ag values before and after NACT in predicting the efficacy of NACT for cervical SCC were 0.839 (95%CI: 0.717-0.965, P<0.001) and 1.000 (95%CI: 1.000-1.000, P<0.001), respectively, with the optimal cut-off values of 3.0 ng/mL and 0.6 ng/mL, respectively. ④The results of multiple unconditional logistic regression analysis of influencing factors of NACT efficacy in cervical SCC showed that the serum SCC-Ag value before NACT and changes of serum SCC-Ag values before and after NACT both were independent predictors of NACT sensitivity of cervical SCC (OR=0.365, 95%CI: 0.224-0.608, P<0.001; OR=0.984, 95%CI: 0.899-0.998, P<0.001). ⑤Among 68 patients with cervical SCC in this study, the positive rate of serum SCC-Ag before NACT in patients with vascular metastasis was higher than those without vessel metastasis, and the positive rates of serum SCC-Ag after NACT in patients with lymph node metastasis, vascular metastasis, International Federation of Gynecology and Obstetrics (FIGO) stage Ⅱ_A2 were significantly higher than those without lymph node metastasis, vascular metastasis, and stage Ⅰ_B2, respectively, and all the differences were statistically significant (P=0.007, P<0.001, P =0.035, P<0.001). ⑥Among 68 patients with cervical SCC in this study, 13 cases relapsed, with a recurrence rate of 19.1% (13/68). The serum SCC-Ag value before NACT in patients with recurrence was (7.1±1.1) ng/mL, which was higher than that of those without recurrence (4.7±1.5) ng/mL, and the difference was statistically significant (t=5.253, P<0.001).

Whether serum SCC-Ag value and its changes can be used as effective predictors of NACT sensitivity of cervical SCC, and whether they can be used as detection indexes of cervical SCC recurrence or not, it still remains to be further confirmed by large-sample, multi-center, and randomized controlled studies as the sample size included in this study is relatively small.